Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Coral Drugs Private Limited
03 1Axplora
04 1Fermion Oy
05 1Amphastar Pharmaceuticals
06 1Astellas Pharma
07 1Cipla
08 2Industriale Chimica
09 1Lusochimica
10 1MSN Laboratories
11 1Sicor Societa Italiana Corticosteroidi Srl
12 1TAPI Technology & API Services
13 1Viatris
14 1Blank
01 5FORMOTEROL FUMARATE
02 3FORMOTEROL FUMARATE DIHYDRATE
03 1FORMOTEROL FUMARATE DIHYDRATE MICRONIZED
04 2FORMOTEROL FUMARATE DIHYDRATE USP
05 2FORMOTEROL FUMARATE USP
06 1FORMOTEROL FUMARATE USP [ROUTE CODE "FL"]
07 1FORMOTEROL FUMERATE
01 1Finland
02 1Germany
03 3India
04 1Israel
05 4Italy
06 1Japan
07 1Spain
08 2U.S.A
09 1Blank
01 11Active
02 4Inactive
01 7Complete
02 8Blank
GDUFA
DMF Review : Complete
Rev. Date : 2017-06-16
Pay. Date : 2017-05-10
DMF Number : 16628
Submission : 2003-06-03
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 30324
Submission : 2016-06-04
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32936
Submission : 2018-07-27
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-19
Pay. Date : 2019-06-25
DMF Number : 33894
Submission : 2019-07-12
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-05-17
Pay. Date : 2018-03-19
DMF Number : 20178
Submission : 2007-04-24
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2017-09-14
Pay. Date : 2017-06-20
DMF Number : 20199
Submission : 2007-01-18
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-05-02
Pay. Date : 2013-01-22
DMF Number : 23848
Submission : 2010-05-10
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-10-24
Pay. Date : 2018-07-26
DMF Number : 28011
Submission : 2014-03-03
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-12-03
DMF Number : 21357
Submission : 2008-02-22
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 19202
Submission : 2006-02-21
Status : Active
Type : II
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